Associate Director, Clinical Development Medical Director (MD Required)

Role Summary

The Associate Director, Clinical Development Medical Director is responsible for the medical & scientific integrity of one or more clinical trials, ensuring patient wellbeing and high-quality trial design and execution. The role collaborates with clinical and medical colleagues, clinical operations, and other functional lines to deliver quality protocols and clear interpretation of trial data. This position may perform medical monitoring and serves as the primary contact for external investigators and internal study teams on clinical/medical aspects of the protocol.

Responsibilities

• Performs medical monitoring on one or more clinical trials: provides study-related medical information and assistance, including medical questions from investigators, site personnel and non-study health care providers; safety findings, medical issues, and complex serious adverse events; audits or inspection medical responses; contributes to final significant quality event medical assessments.
• Jointly with clinical colleagues, conducts and documents periodic safety data reviews and ongoing clinical/medical data review. Reviews required safety text and endorses significant medical changes in the Informed Consent Document.
• Provides clinical/medical input to support development of the protocol design document (PDD) and leads or supports protocol development to maximize operational efficiency, trial quality and participant/site engagement, minimizing amendments or quality issues. Partners with/supports the Global Development Lead in governance review and approval process.
• Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters. Provides clinical/medical input to data collection tools; input to SAP, TLFs and BDR. Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.
• Provides clinical/medical input to the Integrated Quality Management Plan (IQMP); reviews and approves final document. Establishes Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, data provision and documentation of outcomes.
• Inputs to, reviews, and approves Risk Management and Safety Review Plan; ensures activities are conducted per the plan and partners with key stakeholders to develop risk mitigations. Reviews and approves country/site selection and contributes to site training materials. Serves as primary contact for protocol-related clinical/medical questions.
• Reviews, reports and manages protocol deviations; reviews patient-level and cumulative data per the data review plan across one or more studies; reviews safety data, SAE reports, TME‚Äôs, DME‚Äôs and ensures clinical documents are updated; tracks SAEs and leads data presentation in Safety Review Team meetings.
• May act as medical monitor for one or more trials; ensures TMF compliance for clinical documents; inputs/ reviews Clinical Study Report including narratives; supports safety/efficacy data disclosure and trial conclusions; contributes to primary publications.
• Provides clinical support during audits/inspections and may contribute to regulatory filings (e.g., Pediatric Investigational Plan, IB, IND/NDA Annual Reports, PSURs) if required; supports responses to regulatory queries and CTAs.
• Contributes to continuous improvement and innovative approaches to maximize trial effectiveness.

Qualifications

• Required: Medical degree (MD, DO, MBBS, MBChB) with Clinical Research experience; licensed to prescribe medicines independently for at least 2 years post-internship; in good standing with Medical Licensing Authority; clinical research experience in phase 3/pivotal space; demonstrated scientific writing skills with publications, posters, abstracts, or presentations.
• Preferred: Clinical Research experience in industry/CRO; cardiometabolic disease experience; extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management; strong verbal and written communication skills in English; demonstrated leadership, project management, and ability to influence and coach others.

Skills

• Clinical development expertise; medical monitoring; data review and safety management; protocol development and amendments; regulatory knowledge; strong communication and collaboration skills; ability to manage multiple stakeholders and study teams.

Education

• MD/DO/MBBS/MBChB or equivalent medical degree; active medical license in good standing.

Additional Requirements

• Global travel may be required.
• Hybrid work arrangement: on-site ~2.5 days per week within commuting distance.